BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON TRACH-VENT

    MDR report key: 4834355 · Received June 9, 2015

    Report

    Report Number
    8040412-2015-00130
    Event Type
    Malfunction
    Date Received
    June 9, 2015
    Date of Event
    May 12, 2015
    Report Date
    May 24, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    QN#(B)(4). THE DEVICE SAMPLE WAS RETURNED FOR EVALUATION, BUT THE INVESTIGATION IS INCOMPLETE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    QN#(B)(4). THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND THERE WERE NO ISSUES FOUND THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE. THE DEVICE WAS MANUFACTURED ACCORDING TO RELEASE SPECIFICATION. THREE SAMPLES WERE RETURNED FOR EVALUATION. A VISUAL EXAM WAS PERFORMED AND IT WAS OBSERVED THAT THERE WAS A BURR ON THE CONNECTION PORT. BASED ON THE VISUAL EXAM, THE REPORTED COMPLAINT WAS CONFIRMED. A SCAR WAS OPENED TO THE SUPPLIER OF THE PART.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THERE IS A BURR/FOREIGN MATERIAL ON THE CONNECTION PORT OF THE TRACH-VENT. NO PATIENT INJURY REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THERE IS A BURR/FOREIGN MATERIAL ON THE CONNECTION PORT OF THE TRACH-VENT. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372222 HUDSON TRACH-VENT TRACH-VENT FILTER CAH TELEFLEX MEDICAL 201434J

    Patients

    Seq Age Sex Outcome Treatment
    1